药物动力学处置中的双峰现象重新审视
Malaz Yousef1, Dion R Brocks1, Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Centre for Pharmacy and Health Research, University of Alberta, Edmonton, AB, T6G 2E1, Canada.
Clinical pharmacokinetics
|August 13, 2025
概括
多重峰值,或在一剂药物后观察多个药物度峰值,使药物的疗效和生物等价性复杂化. 本综述确定了新的原因,并探索了用于更好的药物开发的先进建模.
科学领域:
- 药理动力学和药物新陈代谢
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 药物动力学多重峰值,即单剂后药物度在血中的两个或两个以上峰值,使药物动力学参数的解释复杂化.
- 这一现象显著影响了关于药物有效性,生物等效性和治疗药物监测的临床决策.
研究的目的:
- 重新检查和扩展已知的物理化学,配方相关的,和多重峰值的生理原因.
- 探索专用配方,如脉动性药物递送系统 (PDDS) 在管理这种复杂的药物动力学行为的作用.
- 突出显示具有多个峰值的药物的先进建模工具和生物等价性考虑.
主要方法:
- 对现有和新型机制的综合文献综述,这些机制有助于多重峰值.
- 探索专门的药物输送系统及其对吸收概况的影响.
- 讨论先进的建模技术,包括基于生理学的药理动力学 (PBPK) 建模.
- 对多峰药物产品的生物等价性评估策略的分析,例如曲线下的部分面积 (pAUC).
主要成果:
- 确定了多重峰值的新贡献因素,包括淋巴吸收,肠胃和肝肠循环,双重吸收途径,过量服用和药物虫.
- 证明了脉冲性药物递送系统 (PDDS) 的潜力,可以影响和潜在地减轻多重峰值.
- 突出了PBPK建模在阐明复杂的吸收概况和指导药物开发中的有用性.
- 强调了像pAUC这样的特定生物等价度指标对产品具有多个峰值的重要性.
结论:
- 了解并准确地建模多重峰值对于优化药物开发过程至关重要.
- 先进的建模和制定策略可以帮助管理多重峰值的复杂性.
- 改进这种现象的特征支持精确的剂量,治疗监测和知情的监管决策.
相关概念视频
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